An Overview Of The ICH-Q3D Heavy Metal Regulations

July 14, 2017

The presence of residual metal impurities during drug manufacturing has become a major issue in the pharmaceutical industry in recent years, prompting a wide amount of interest in solutions for their safe and efficient removal.

Spotlight

Rush University Medical Center

Rush University Medical Center is an academic medical center that includes a 671-bed hospital serving adults and children, the 61-bed Johnston R. Bowman Health Center and Rush University. Rush University is home to one of the first medical colleges in the Midwest and one of the nation's top-ranked nursing colleges, as well as graduate programs in allied health, health systems management and biomedical research. The Medical Center also offers more than 70 highly selective residency and fellowship programs in medical and surgical specialties and subspecialties.

OTHER WHITEPAPERS
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Securing the modern pharmaceutical supply chain

whitePaper | April 22, 2022

Members of the Health-ISAC community have produced a security framework for the pharmaceutical supply chain comprising this CISO guide.

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DEVELOPING AND OPTIMIZING CLEANING PROCESSES

whitePaper | November 1, 2022

Equipment cleaning in manufacturing companies is often not given the same emphasis as other processes. It can be viewed as a task.

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Getting serious about serialization: A comprehensive look at thelegislation shaping U.S. pharmaceutical supply chains

whitePaper | October 7, 2022

The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

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Overcoming technical challenges in cell-based high throughput screens

whitePaper | November 11, 2022

Tremendous technological advancements in automated biotechnology and combinatorial chemistry have led to the widespread implementation of high throughput screening (HTS) for drug discovery since the early 1990s.

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The Next Generation of Rare Disease Drug Policy

whitePaper | April 7, 2022

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the country or one in which “there is no reasonable expectation” of recovering research and development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis, and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

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Simulation in the pharmaceutical industry

whitePaper | November 24, 2022

The pharmaceutical industry will face many challenges over the next decade, from industry-wide trends to new operational pressures. The key to meeting these challenges is adopting an agile, scalable and efficient approach to drug discovery and manufacturing.

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Spotlight

Rush University Medical Center

Rush University Medical Center is an academic medical center that includes a 671-bed hospital serving adults and children, the 61-bed Johnston R. Bowman Health Center and Rush University. Rush University is home to one of the first medical colleges in the Midwest and one of the nation's top-ranked nursing colleges, as well as graduate programs in allied health, health systems management and biomedical research. The Medical Center also offers more than 70 highly selective residency and fellowship programs in medical and surgical specialties and subspecialties.

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